Medical Device Registration and Approval in Indonesia
General country-specific regulatory information is provided on this page for medical device registration and approval in Indonesia. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Indonesia, to expedite the preparation of your medical device or IVD registration application.
Medical Device Regulations and Classification in Indonesia
REGULATORY AUTHORITY: Medical devices are regulated by the Indonesian National Agency of Drug and Food Control (NA-DFC).
CLASSIFICATION SYSTEM: Risk Based Classification: Classes I, IIa, IIb and III.
TIMEFRAME: The registration process takes 45 working days for Class I devices, 90 working days for Class IIa and IIb devices, and 120 working days for Class III devices.
LICENSE VALIDITY: Licenses issued in Indonesia expire after 5 years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required.
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